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Clinical Trials/2023-507776-42-00
2023-507776-42-00
Recruiting
Phase 3

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)

Merck Sharp & Dohme LLC63 sites in 8 countries194 target enrollmentStarted: May 17, 2024Last updated:
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InterventionsMK-1084KEYTRUDA 25 mg/mL concentrate for solution for infusionPlacebo to MK-1084 50 mgPlacebo to MK-1084 25 MG

Overview

Phase
Phase 3
Status
Recruiting
Enrollment
194
Locations
63
Primary Endpoint
1. Progression-free survival (PFS)
OverviewEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

  1. To compare MK-1084 plus pembrolizumab with placebo plus pembrolizumab with respect to PFS assessed according to RECIST 1.1 by BICR

To compare MK-1084 plus pembrolizumab with placebo plus pembrolizumab with respect to OS

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
  • •Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
  • •Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research
  • •If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to < Grade 1 or baseline
  • •If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
  • •If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
  • •If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable

Exclusion Criteria

  • •Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible.
  • •Has known active central nervous system metastases and/or carcinomatous meningitis
  • •Known additional malignancy that is progressing or has required active treatment within the past 3 years
  • •Has active autoimmune disease that has required systemic treatment in the past 2 years
  • •Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • •Is HIV-infected and has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
  • •Has history of allogenic tissue/solid organ transplant
  • •Has not fully recovered from any effects of major surgical procedure
  • •Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
  • •Has known history of, or active, neurologic paraneoplastic syndrome

Arms & Interventions

MK-1084, MK-1084

Test

Intervention: MK-1084 (Drug)

KEYTRUDA 25 mg/mL concentrate for solution for infusion

Test

Intervention: KEYTRUDA 25 mg/mL concentrate for solution for infusion (Drug)

Placebo to MK-1084 50 mg, Placebo to MK-1084 25 MG

Placebo

Intervention: Placebo to MK-1084 50 mg (Drug)

Placebo to MK-1084 50 mg, Placebo to MK-1084 25 MG

Placebo

Intervention: Placebo to MK-1084 25 MG (Drug)

Outcomes

Primary Outcomes

1. Progression-free survival (PFS)

1. Progression-free survival (PFS)

2. Overall survival (OS)

2. Overall survival (OS)

Secondary Outcomes

  • 1. Objective response rate (ORR)
  • 2. Duration of response (DOR)
  • 3. Number of participants who experience one or more Adverse Events (AEs)
  • 4. Number of participants who discontinue study treatment due to an AE
  • 5. Change from baseline in global health status/quality of life (items 29 and 30) score, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
  • 6. Change from baseline in the physical functioning (items 1-5) score, on the EORTC QLQ-C30
  • 7. Change from baseline in the role functioning (items 6-7) score, on the EORTC QLQ-C30
  • 8. Change from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30
  • 9. Change from baseline in the cough (item 31) score, on the EORTC QLQ- LC13
  • 10. Change from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13
  • 11. Time to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30
  • 12. TTD in the physical functioning (items 1-5) score, on the EORTC-QLQ-C30
  • 13. TTD in the role functioning (items 6-7) score, on the EORTC QLQ-C30
  • 14. TTD in the dyspnea (item 8) score, on the EORTC QLQ-C30
  • 15. TTD in the cough (item 31) score, on the EORTC QLQ-Lung Cancer version (LC13)
  • 16. TTD in the chest pain (item 40) score, on the EORTC QLQ-LC13

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Azadeh Namakydoust

Scientific

Merck Sharp & Dohme LLC

Study Sites (63)

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